drugset / Trial / NCT02812667
Nivolumab in Combination With Plinabulin in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC)
NaSingle-groupOpen-labelTreatment
Summary
The purpose of the study is to determine whether plinabulin (also known as BPI-2358) has an effect on cancer and body in combination with nivolumab, a standard treatment for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Plinabulin inhibits tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Plinabulin is an investigational drug, a drug that is not approved for use outside of research studies by regulatory agencies. Up to 38 patients will be enrolled.
Timeline
- Start
- 2016-08-29
- Primary completion
- 2024-11-24
- Completion
- 2025-10-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plinabulin | Small molecule | 3.5 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Plinabulin | Small molecule | 40 mg/m2 | Intravenous |
| Background | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |